MAUDE Adverse Event Report: STRYKER SPINE-US LUXOR ARM POST; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48250240
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sales representative reported that the two retractor arm posts were inspected and free of any visible damage.The two arm posts were taken apart and the issues were still not resolved after putting them back together.A supplemental report will be provided upon completion of the investigation.
Event or Problem Description
It was reported that the retractor arm post would not tighten to the bed in the operating room.A back up arm post was also slipping when trying to tighten and eventually failed as well.The procedure was completed successfully with a third post.There was no delay in surgery or adverse consequences to the patient.
Additional Manufacturer Narrative
Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The most likely cause of the reported event was determined to be normal wear and tear of the instrument.
Event or Problem Description
It was reported that the retractor arm post would not tighten to the bed in the operating room.A back up arm post was also slipping when trying to tighten and eventually failed as well.The procedure was completed successfully with a third post.There was no delay in surgery or adverse consequences to the patient.

• Brand Name: LUXOR ARM POST
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7278671
• Report Number: 0009617544-2018-00045
• Device Sequence Number: 16558065
• Product Code: LXH
• UDI-Device Identifier: 07613327266177
• UDI-Public: (01)07613327266177
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48250240
• Device Catalogue Number: 48250240
• Device Lot Number: 132808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 02/16/2018
• Supplement Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1